A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)
Ranok Therapeutics (Hangzhou) Co., Ltd.
Summary
This is a first in human, Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL). This is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.
Description
In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive RNK05047 at the starting dose of 0.75 mg/kg. In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the study. Tumor types for these cohorts will be determined based on data from the dose-escalation phase of the stu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologically documented locally advanced or metastatic solid tumor * Refractory or intolerant to all available standard-of-care therapies for advanced disease * Measurable disease * Archived tumor tissue collected * ECOG Performance Status of 0 or 1 * BMI ≥ 18 kg/m2 * Adequate liver, renal, hematologic, and coagulation parameters * Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion * Males and females of childbearing potential must agree to use a highly effec…
Interventions
- DrugRNK05047
RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week).
Locations (5)
- Emory University Winship Cancer InstituteAtlanta, Georgia
- Norton Cancer InstituteLouisville, Kentucky
- Weill Cornell - NY Presbyterian HospitalNew York, New York
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality
- Beijing Cancer HospitalBeijing, Beijing Municipality